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NCT Number: NCT04377633

Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.

It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.

It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients (aged 65 years and over);
  • Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
  • Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).

Exclusion criteria

  • Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
  • Inability to communicate before surgery (coma, profound dementia or language barrier);
  • Craniocerebral injury or neurosurgery;
  • Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of <24 hours.

Treatment and study plan

Oral handover

Procedure

Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.

Checklist handover

Procedure

Anesthesia handover during surgery will be performed according to a structured handover checklist.

Primary outcomes

  1. A composite incidence of all complications within 30 days after surgery.

    Time frame: Up to 30 days after surgery.

    Include organ injury (delirium, acute kidney injury, and myocardial injury) within 3 days and other major complications (class II or higher on Clavien-Dindo classification) within 30 days after surgery.

Secondary outcomes

  1. Intensive care unit admission after surgery.

    Time frame: Up to 30 days after surgery.

    Intensive care unit admission after surgery.

  2. Length of stay in the intensive care unit after surgery.

    Time frame: Up to 30 days after surgery.

    Length of stay in the intensive care unit after surgery.

  3. Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.

    Time frame: Up to 3 days after surgery.

    Delirium is diagnosed with the Confusion Assessment Method. Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) Criteria. Acute myocardial injury is diagnosed according to the serum cardiac tropinin I level.

  4. Incidence of major complications within 30 days after surgery.

    Time frame: Up to 30 days after surgery.

    Major complications are defined as newly occurred conditions that are harmful to patients' recovery and required medical therapy, i.e., class II or higher on the Clavien-Dindo classification.

  5. Length of hospital stay after surgery.

    Time frame: Up to 30 days after surgery.

    Length of hospital stay after surgery.

  6. All-cause mortality within 30 days after surgery.

    Time frame: Up to 30 days after surgery.

    All-cause mortality within 30 days after surgery.

Other outcomes

  1. Pain intensity within 3 days after surgery.

    Time frame: Up to 3 days after surgery.

    Pain intensity is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain.

  2. Subjective sleep quality within 3 days after surgery.

    Time frame: Up to 3 days after surgery.

    Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 6, 2020
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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